Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
Study NCT ID:
NCT06595550
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During Fasting Ramadan.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067816', 'term': 'Whey Proteins'}], 'ancestors': [{'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2024-09-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoglycemia incidence rate', 'timeFrame': '1 month', 'description': 'number of hypoglycemic events (blood glucose \\<70mg/dl) as detected by flash glucose monitoring'}], 'secondaryOutcomes': [{'measure': 'Percentage Time-below-range (TBR), time-above-range (TAR), and time-in-range (TIR) prior to and following whey protein consumption 2.', 'timeFrame': '1 month', 'description': 'Glucose profiles as detected by flash glucose monitoring'}, {'measure': 'Glycemic control (HbA1c) and GMI during protein consumption', 'timeFrame': '1 month', 'description': 'glucose parameters detected by flash glucose monitoring by and lab'}, {'measure': 'number of days they needed to brake the fast during each week', 'timeFrame': '1 month', 'description': 'number of days fast broken during each week'}, {'measure': 'Patient preferences through questionnaire', 'timeFrame': '1 month', 'description': 'to compare patient satisfaction'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type1 Diabetes', 'Fasting', 'Nutrition, Healthy']}, 'descriptionModule': {'briefSummary': 'Cross over randomized design for adding whey protein to Suhoor meal for patients with T1DM during fasting Ramadan', 'detailedDescription': 'Patients with type1 diabetes who intend to fast will be supplied with dietary supplement "Whey protein" to be taken with Suhoor (predawn meal) for one week during Ramadan. They will be then crossed over to not taking the whey protein for another week. the order of taking whey protein will be randomized.\n\nDuring both weeks patients will be monitored through flash continuous glucose monitoring and data will be compared in regards to incidence and timing of hypoglycemia, hyperglycemia, and time in target range.\n\nAfter Ramadan data will be collected on number of days they had to brake fast due to low blood sugar during both weeks and overall satisfaction with using whey protein during Ramadan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Type 1 Diabetes Mellitus\n2. Age \\>14 years\n3. Committed to do Regular SMBG or on CGM\n4. On Multiple Daily Injections or insulin pumps\n5. On carbohydrate counting for meal dosing\n6. Have previously fasted Ramadan\n7. willing to fast Ramadan this year\n8. Well-educated about requirements for fasting Ramadan\n\nExclusion Criteria:\n\n1. Hypoglycemia unawareness\n2. Cognitive impairment or learning disability\n3. Renal and hepatic impairment\n4. Adrenal insufficiency\n5. Pregnancy\n6. Alcohol consumption\n7. Any diagnosed psychiatric disease\n8. Sensor-augmented insulin pumps\n9. HbA1c \\>12%\n10. Already on protein supplements'}, 'identificationModule': {'nctId': 'NCT06595550', 'briefTitle': 'The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During Fasting Ramadan.', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah International Medical Research Center'}, 'officialTitle': 'The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During the Fasting Holy Month of Ramadan: a Randomized, Crossover Study', 'orgStudyIdInfo': {'id': 'ICT23J/001/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'whey protein', 'description': 'whey protein with suhoor', 'interventionNames': ['Dietary Supplement: Whey protein']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'no whey protein', 'description': 'no whey protein with suhoor', 'interventionNames': ['Dietary Supplement: no Whey protein']}], 'interventions': [{'name': 'Whey protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Powder milk', 'armGroupLabels': ['whey protein']}, {'name': 'no Whey protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Powder milk', 'armGroupLabels': ['no whey protein']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'King Abdullah International Research Centre', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'overallOfficials': [{'name': 'Reem Alamoudi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of National Guard Health Affairs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdullah International Medical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}